WILLFACT 500 I.U POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Transcript

If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
No effects on the ability to drive or use machines have been observed.
Willfact contains sodium
One 5 ml vial (500 IU) of Willfact contains 0.15 mmol (3.4 mg) sodium.
One 10 ml vial (1000 IU) of Willfact contains 0.3 mmol (6.9 mg) sodium.
One 20 ml vial (2000 IU) of Willfact contains 0.6 mmol (13.8 mg) sodium.
You should take it into consideration if you are on a salt-free or low-salt diet.

3. HOW TO USE WILLFACT
Treatment should only be initiated under the supervision of a physician experienced
in the treatment of haemostatic disorders.
Dosage
The dose you take depends on your health condition and body weight.
The first dose of Willfact is 40 to 80 IU/kg for the treatment of haemorrhage or trauma,
in conjunction with the required amount of factor VIII product, calculated according to
your baseline plasma level of FVIII:C, in order to achieve an appropriate plasma level of
FVIII:C, immediately before the intervention or as soon as possible after the onset of the
bleeding episode or severe trauma.
If required, you will receive further doses of Willfact of 40 to 80 IU/kg per day in
one or two injections daily over one to several days.
Willfact can also be administered as long-term prophylaxis; the dose level
is determined individually in this case. Willfact doses between 40 and 60 IU/kg
administered two to three times per week reduce the number of haemorrhagic
episodes.
Please talk to your doctor if you feel that the effect of Willfact is too strong or too
weak.
If you use more Willfact than you should:
No symptoms of overdose with Willfact have been reported.
However, the risk of thrombosis cannot be excluded in case of major overdose.
If you have any further questions on the use of this medicine, ask your doctor,
pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
The following side-effects occurred “uncommonly”: (may affect up to 1 in 100
people):
Hypersensitivity - or allergic reactions
In some cases, the following signs may progress to severe allergic reaction
(anaphylaxis) including shock.
Accelerated heartbeat (tachycardia)
Tightness of the chest

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Willfact contains
The active substance is: human von Willebrand factor (500 IU, 1000 IU or 2000 IU),
expressed in International Units (IU) of Ristocetin Cofactor activity (VWF:RCo).
After reconstitution with 5 ml (500 IU), 10 ml (1000 IU) or 20 ml (2000 IU) of
water for injections, one vial contains approximately 100 IU/ml of human von
Willebrand factor.
Before the addition of albumin, the specific activity is greater than or equal to 50 IU
of VWF: RCo/mg of total protein.

The early signs of allergic reactions could be hives, nettle rash, tightness of
the chest, wheezing, hypotension and sudden severe allergic reaction. If one
of these effects occurs, immediately stop the treatment and alert a doctor to
start appropriate treatment depending on the type and severity of the reaction.
The following side-effects were observed “rarely” (may affect up to 1 in 1000
people):
Fever
The following side-effects occurred “very rarely” (may affect up to 1 in 10000
people):
Antibodies (inhibitors) against VWF: very rarely, proteins may be formed in
patients with von Willebrand disease, especially type 3 patients, which neutralise
the effect of VWF. These proteins are called antibodies or inhibitors. However, this
has never been observed during Willfact treatment. Patients treated with VWF
should be carefully monitored by their doctors for the development of inhibitors
by appropriate clinical observations and laboratory tests. If such inhibitors occur,
the condition will manifest itself as an inadequate clinical response. The antibodies
form antibody-antigen complexes and occur concomitantly to anaphylactic
reactions.
After correction of the factor Willebrand deficiency, you must be monitored for
early signs of thrombosis or disseminated intravascular coagulation and receive
treatment to prevent thrombosis in situations involving an increased risk of
thrombosis (after operations, during confinement to bed, in cases of deficiency in
a coagulation inhibitor or fibrinolytic enzyme).
If you receive FVIII-containing VWF preparations, the risk of thrombosis may also
be increased due to persistently elevated FVIII:C plasma levels.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE WILLFACT
Store in the original package in order to protect from light. Do not store above
25°C. Do not freeze.
The product should be used immediately after reconstitution. However, its
stability has been demonstrated for 24 hours at 25°C.
Keep product out of the the sight and reach of children.
Do not use the product after the expiry date stated on the vial label and carton.
Do not use this medicine if you notice that the solution is cloudy or that it
contains any deposit.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist or your nurse how to throw away medicines you no longer use. These
measures will help protect the environment.

Other medicines and Willfact
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or
might take/use any other medicines.
Willfact with food and drink
There are no known interactions of VWF preparations with foods or drinks.
Therefore you do not have to avoid any specific foods or drinks.
Pregnancy and breast-feeding
Willfact should be used during pregnancy and breastfeeding only if it is clearly
indicated. The safety of Willfact during pregnancy and breastfeeding has not
been evaluated in controlled clinical studies. Animal studies are not sufficient to
establish its safety with respect to fertility, pregnancy and development of the child
during pregnancy and after birth.

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Reconstitution:
The currently applicable guidelines for aseptic procedures must be followed.
The transfer system is only used to reconstitute the drug, as described below.
It is not intended in administering the drug to the patient.

• Bring the two vials (powder and solvent) to a
temperature not above 25°C.

• Remove the protective cap from the solvent vial
(water for injections) and from the powder vial.
• Disinfect the surface of each stopper.

!

The following information is intended for medical or healthcare professionals
only:

Administration:

WILLFACT
500 IU 1000 IU 2000 IU

• Hold the vial of reconstituted product in vertical
position while screwing a sterile syringe onto the
Mix2Vial device. Then slowly draw the product up
into the syringe.
• Once the product has been transferred to the
syringe, firmly hold the syringe (with the piston
pointing downward), unscrew the Mix2Vial device
and replace it with an intravenous or butterfly
needle.
• Expel the air from the syringe and insert into the
vein after disinfecting the surface.
• Inject slowly by intravenous route immediately after
reconstitution as a single dose at a maximum rate of
4 ml/minute.

Human von Willebrand factor
Powder and solvent for solution for injection
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effect not listed in this leaflet. See section 4.

Any unused product or waste material should be disposed of in accordance with
local requirements.

In this leaflet:

• Remove the cap from the Mix2Vial device. Without
removing the device from its packaging, attach
the blue end of the Mix2Vial to the stopper of
the solvent vial.

1. What Willfact is and what it is used for
2. What you need to know before you use Willfact
3. How to use Willfact
4. Possible side effects
5. How to store Willfact
6. Contents of the pack and other information

1. WHAT WILLFACT IS AND WHAT IT IS USED FOR
Willfact is a medicine used to stop bleeding that contains human von Willebrand
factor (VWF) as active ingredient.

• Remove and discard the packaging. Take care not
to touch the newly-exposed part of the device.

Willfact is indicated in the prevention and treatment of surgical or other bleeding
in patients with von Willebrand disease when desmopressin (DDAVP) treatment
alone is ineffective or contra-indicated.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE WILLFACT
Contraindications

• Turn the solvent vial-device assembly over and
attach to the powder vial using the transparent
part of the device. The solvent will automatically
transfer to the powder vial. Hold the assembly and
gently swirl to completely dissolve the product.

Do not use Willfact
if you are allergic to human von Willebrand factor or to any of the other
ingredients of this medicine (listed in section 6).
if you suffer from haemophilia A.
Warnings and precautions:
Your treatment with Willfact should always be supervised by a physician
experienced in the treatment of haemostatic disorders.
If you experience heavy bleeding and a blood examination shows that your Factor
VIII blood value is reduced, you will receive the VWF preparation in addition to a
Factor VIII preparation within the first twelve hours.

• Now, holding the reconstituted product part
in one hand and the solvent part in the other,
unscrew the Mix2Vial device to separate the vials.

The solution should be clear or slightly opalescent, colourless or slightly
yellowish. Do not use solutions that are cloudy or have deposits.

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!

The powder generally dissolves instantaneously and should have dissolved in less
than 10 minutes.

Allergic reactions
As with every protein medicine for intravenous use derived from human blood
or plasma, hypersensitivity reactions in the form of an allergy may occur.
During your injection, you will be observed specifically to determine whether you
experience any early signs of hypersensitivity, e.g. stinging, hives (generalised
urticaria), tightness of the chest, wheezing, drop in blood pressure (hypotension)
and allergic severe reactions (anaphylaxis). If these symptoms occur, the injection
will be interrupted immediately.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Risk of thrombosis
Blood vessels may also become blocked by blood clots (thromboses). This risk
exists particularly if your previous medical history or laboratory results indicate that
you present certain risk factors. In this case you will be monitored very carefully
for the early signs of thrombosis, and a preventative treatment (prophylaxis)
against vein blockages by blood clots should be introduced.
When using a Factor VIII-containing VWF product, your physician should be aware
that the treatment may cause an excessive rise in FVIII:C. If you receive such FVIIIcontaining VWF product, your physician should monitor your FVIII:C plasma level
regularly. This ensures that your FVIII:C plasma level is not sustained excessive,
which may increase the risk of thrombotic events.

Limited effectiveness
It is possible that, in patients with von Willebrand disease, especially type 3
patients, proteins may be formed that neutralise the effect of VWF. These proteins
are called antibodies or inhibitors. If the laboratory results give corresponding
indications, or if the bleeding does not stop despite a sufficient dose of Willfact,
your physician will check whether VWF inhibitors are being formed in your body.
If these inhibitors are present in high concentration, treatment with VWF may not
be effective, and other treatment options should be considered. The new treatment
will be provided by a physician who has experience in the treatment of haemostatic
disorders.
Virus safety
When medicines are made from human blood or plasma, certain measures are put
in place to prevent infections being passed on to patients. These include:
- careful selection of blood and plasma donors to make sure those at risk of
carrying infections are excluded,
- the testing of each donation and pools of plasma for signs of virus/infections,
- the inclusion of steps in the processing of the blood or plasma that can inactivate
or remove viruses.
Despite these measures, when medicines prepared from human blood or plasma
are administered, the possibility of passing on infection cannot be totally excluded.
This also applies to any unknown or emerging viruses or other types of infections.
The measures taken are considered effective for enveloped viruses such as human
immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus. The measures
taken may be of limited value against non-enveloped viruses such as hepatitis A
Virus and parvovirus B19. Parvovirus B19 infection may be serious for pregnant
women (fetal infection) and for individuals whose immune system is depressed or
who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).
Vaccinations
Your doctor may recommend that you consider vaccination against hepatitis A and
B if you regularly/repeatedly receive human plasma-derived von Willebrand factor.
Recording of batch number
It is strongly recommended that every time you receive a dose of Willfact the name
and batch number of the medicine are recorded in order to maintain a record of
the batches used.
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.